FDA OKs expanded trial for Precision Biopsy’s ClariCore prostate biopsy device

Precision Biopsy said today it won an investigational device exemption from the FDA to expand the trial of its ClariCore biopsy system, now looking to enroll prostate cancer patients in the newly cleared Transrectal Ultrasound and MR/Fusion arms of the study.

The ClariCore system is designed for the spectral analysis of tissue samples during biopsies to “rapidly classify” tissue as normal or suspicious using an optical fiber and companion console designed to minimize the number of samples taken by up to 90%, the company said.

“The approval from the FDA marks an important step forward in our efforts to finalize development of the ClariCore Optical Biopsy System and help to improve the biopsy process for patients being evaluated and monitored for prostate cancer, the second-most deadly cancer in men,” CEO Amir Tehrani said in a press release.

The Aurora, Colo.-based company said it has already enrolled 33 patients in its retropubic radical prostatectomy arm of the study.

The company’s approximately 200-patient trial of the ClariCore system aims to collect prostate tissue and associated optical signatures to help develop the systems’ real-time tissue classification algorithm.

“We are looking forward to enrolling prostate biopsy patients in the Cohort A clinical trial using the ClariCore Optical Biopsy system. ClariCore is a breakthrough technology that should both benefit patient outcomes and also reduce healthcare costs,” Dr. Neal Shore of the Carolina Urologic Research Center said in prepared remarks.

“The ability to expand the trial is an important milestone in the development of the ClariCore system and we are excited by the progress achieved by the Precision Biopsy team,” Precision Biopsy parent company Allied Minds senior veep Dr. Omar Amirana said in a prepared statement.

Precision Biopsy applied for the expansion in March, looking to add the Transrectal Ultrasound and MR/Fusion arms to collect data from prostate cancer patients.

All 3 arms of the company’s Cohort A clinical trial look to collect prostate tissue and associated optical responses to help develop the ClariCore System’s real-time tissue classification algorithm, the company said. A total of 200 patients are slated to be enrolled in the algorithm development trial.

Last October, Precision Biopsy said it raised $33.6 million in a new round of equity financing to support its ClariCore biopsy platform designed to provide prostate tissue classification during biopsy procedures.

Woodford Investment Management led the round, according to Aurora, Colo.-based Precision Biopsy, with investments from its parent company Allied Minds.

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